FDA.reportPublic FDA data

MAXIMUM CURE

Primary DI
00840479202075
Brand
MAXIMUM CURE
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
MC20AF
Published
2026-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894566000MAXIMUM CURE SEALANT WITH FLUORIDEReliance Orthodontic Products, Inc.1989-09-19DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798MC20AF0PreviousHIBCC0
00840479202075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479202075008404792020758404792020750840479202075

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113170088
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798EMHAPR0EtchmasterEMHAPR2021-07-13
D798ASK0ASKASKASK2016-07-25
D798ASKU0ASKASKUASKU2016-07-25
D798EMCO20EtchmasterEMCO2EMCO22016-09-09
D798EMGAS0EtchmasterEMGASEMGAS2016-09-03
D798EMHA0EtchmasterEMHAEMHA2016-09-03
D798EMHAR0EtchmasterEMHAREMHAR2016-09-04
D798EMTLL1EtchmasterEMTLLEMTLL2016-09-04
D798EMTLS1EtchmasterEMTLSEMTLS2016-09-04
D798EMTRL1EtchmasterEMTRLEMTRL2016-09-04
D798EMTRS1EtchmasterEMTRSEMTRS2016-09-04
D798USEP0Ultra SEPUSEP2022-03-03
D798PPA10Perfect A SmilePPA1PPA12019-09-10
D798PPD30Perfect A SmilePPD3PPD32019-09-10
D798EL240EtchantEL24EL242016-08-10
D798EL24C0EtchantEL24CEL24C2016-08-10
D798LBMPPF0LIGHT BONDLBMPPFLBMPPF2016-08-03
D798LBPP0Light BondLBPPLBPP2016-08-03
D798LBS30Light BondLBS3LBS32016-08-03
D798LBS3F0Light BondLBS3FLBS3F2016-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062605SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062612SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062629SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062636SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062643SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062650SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062667SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062674SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062766SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062773SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062780SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062797SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062865SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062872SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062896SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064739SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064746SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067891SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067907SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067914SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067921SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067938SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067945SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067952SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067969SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067976SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067983SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069208SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069215SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069222SolventumSolventum Orthodontics CorporationDYH2026-11-04